[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.

Sponsor:

Information provided by:

[Redacted]

ClinicalTrials.gov Identifier:

NCT01424189

First received: August 25, 2011

Last updated: September 4, 2012

Last verified: NA

History of Changes

Tracking Information
First Received Date ^ICMJE	August 25, 2011
Last Updated Date	September 4, 2012
Start Date ^ICMJE	July 2011
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT01424189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	[Trial of device that is not approved or cleared by the U.S. FDA]
Official Title ^ICMJE	[Trial of device that is not approved or cleared by the U.S. FDA]
Brief Summary
Detailed Description
Study Type ^ICMJE
Study Phase
Study Design ^ICMJE
Condition ^ICMJE
Intervention ^ICMJE
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withheld
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE
Gender
Ages
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT01424189
Other Study ID Numbers ^ICMJE	C-09-036
Has Data Monitoring Committee
Responsible Party	[Redacted]
Study Sponsor ^ICMJE	[Redacted]
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	[Redacted]
Verification Date
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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